DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/11/26 has been entered.
Priority
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Claims Status
Claims 1,2,6 and 9-13 are pending in the application.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1,2,6 and 9-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Abe et al. (US2006/0178339A1), as evidenced by Jung et al. (Analyt. Chem. 79, 2007, 5703-5710) in view of Gulle et al. (US2016/0271228A1) and in further view of Willard et al. (US 2020/0281980A1), as evidenced by Castor Oils safety data sheet 2023.
Abe et al. (US 2006/0178339A1) discloses a hemostatic material and/or a biomedical adhesive comprising a crosslinkable polysaccharide derivative comprising at least one active ester group (abstract; p2, [0014],[0016]; p4, [0063],[0067]; p12, [0149]; p13, [0156],[0158],[0160]) that encompasses the first polysaccharide having a reactive group of the instant claims.
The crosslinkable polysaccharide comprises dextran, CM dextran, pullulan, CM pullulan, hyaluronic acid, etc. (p3, [0027-0028]; p7, [0096]; p14, [0165-0166]; Table 1) that encompasses the dextran, pullulan, hyaluronic acid of the instant claim 6.
The crosslinkable polysaccharide has two or more units of monosaccharide structure in the main skeleton, such as glucose, mannose, galactose, etc. (p5, [0078]) that encompasses the constitutional unit derived from the monosaccharide of the instant claims.
The crosslinkable polysaccharide has a weight-average molecular weight of 5,000 to 2,500,000 (p5, [0079]) that encompasses the molecular weight of the polysaccharide of the instant claim 9.
The active ester group comprises a succinimide ester group, preferably NHS (p3,
[0021],[0042]; p5, [0076]; p7, [0099]) that encompasses the reactive group of General Formula (I).
The crosslinkable polysaccharide derivatives having a reactive group, such as CM dextran-NHS, etc. (Example 3) encompasses the polysaccharide having a reactive group that reacts with a protein to form a crosslinking structure of the instant claims.
CM dextran-NHS has the structure
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214
190
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(Figure 1), as evidenced by Jung et al. (Analyt. Chem. 79, 2007, 5703-5710)
The polysaccharide has a carboxylic acid group (e.g. carboxy group and/or carboxyalkyl group) to form the active ester group (p5, [0080]) that encompasses the
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68
360
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groups of the instant claims.
The composition including the crosslinkable polysaccharide may further contain a polymer, such as a polypeptide or a polysaccharide (p9, [0127-0128]; p10, [0133]).
The polypeptide includes collagen, gelatin, etc. (p10, [0132]) that encompasses the protein of the instant claims and the gelatin of the instant claim 2.
The polysaccharide comprises chitin, chitosan, hyaluronic acid, etc. (p9, [0128]) that
encompasses the second polysaccharide of the instant claim 6.
Abe et al. further discloses that the crosslinked polysaccharide composition may incorporate
additives, such as plasticizers, solvent, petrolatum, paraffin, etc. (p12, [0143],[00151-0152]). These
additives may be used alone or in combination (p12, [0143],[0151]).
The paraffin and petrolatum encompass the paraffin-based solvent of the instant claim 10.
The polysaccharide and polymer composition may be in the form of a paste, powder, sheet, film, etc. (p4, [0056-0057],[0064]; p10, [0133]; p12, [0144], [0149]; p13, [0158]).
Abe et al. does not explicitly disclose the content of a constitutional unit derived from the monosaccharide having the reactive group is 1% by mole to 40% by mole with respect to 100% by mole of the polysaccharide.
Abe et al. further discloses that they polysaccharide derivative contains the active ester group in an amount of 0.1 to 2 mmol/g based on dry weight which can vary depending on the purpose of use (p3, [0022]; p5, [0077]; p7, [0103-0104]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the constitutional unit derived from the monosaccharide of the crosslinkable polysaccharide having a reactive group is 1% by mole to 40% by mole with respect to 100% by mole of the polysaccharide as Abe et al. teaches that the crosslinkable polysaccharide derivative comprises at least one active ester group bound to a constitutional unit and therefore may comprise more than one active ester group, such that the crosslinkable polysaccharide derivative will contain the active ester groups bound at multiple constitutional units in an amount of 0.1 to 2 mmol/g based on dry weight.
Abe et al. does not explicitly disclose the crosslinked polysaccharide composition does not contain water, or a content of water is 0.5% by mass or less with respect to a total mass of the hemostatic material composition.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the polysaccharide and polymer composition of Abe et al. will not contain water or that the content of water is 0.5% by mass or less with respect to a total mass of the hemostatic material composition as the polysaccharide-NHS derivatives are heat-dried and/or freeze-dried (p9, [0121]), the resulting polysaccharide and polymer composition is prepared in non-aqueous volatile organic solvents and subsequently dried in vacuo.
Abe et al. does not disclose that the polymer, such as gelatin, chitin, chitosan, hyaluronic acid, etc. is crosslinked.
Gulle et al. (US2016/0271228A1) discloses a hemostatic composition that comprises a biocompatible polymer in particulate form suitable for use in hemostasis and a hydrophilic polymeric component comprising reactive groups that provides improved hemostatic properties and improved tissue adherence (abstract; p1, [0007-0008]).
The biocompatible polymer comprises gelatin, collagen, chitosan, etc. and is in particulate form (p1, [0014]; p2, [0019]). The polymer preferably comprises crosslinked gelatin (p2, [0020],[0022]).
The hydrophilic polymer comprises a reactive group, such as a succinimidylesters (p1, [0014];
p2, [0021]; p3, [0032]; p4, [0036]).
The hydrophilic polymer is mixed with an organic solvent (p3, [0033]) and the hemostatic composition is provided in a paste form (p4, [0052]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to crosslink the gelatin polymer of Abe et al. to form a particle as Gulle et al.
teaches that crosslinked gelatin particles provide the advantage of improved sealing/hemostatic properties and improved tissue adherence for resulting hemostatic compositions.
Abe et al. does not disclose an average primary particle diameter of crosslinked particles is 200 µm to 700 µm.
The reference of Gulle et al. further discloses that the particle size of the biocompatible polymer, such as gelatin comprises 10 to 1,000 µm, especially 50 to 700 µm (p2, [0027]; p3, [0028],[0031]).
Willard et al. (US 2020/0281980A1) discloses a hemostatic composition (abstract, [0034]) in the form of a particle, film, sheet, etc. (p2, [0011]; p4, [0044],[0047]; p5, [0051]; p6, [0057]) comprising crosslinked polysaccharides, such as dextran (p4, [0046]; p7, [0059]) with proteins (p5-6, [0052]).
The hemostatic agents may comprise microparticles having size of from about 1 to 1000 micrometers, or about 1 to 500 micrometers which can accelerate clot formation (p5, [0052]; p9, [0082]). The hemostatic agents may be sorted according to size and certain portions of the size distribution may be employed for different uses (p9, [0079]).
The hemostatic composition is used for clotting of blood at a wound site in animals, such as mammals (p4, [0046]; p5, [0051]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include crosslinked gelatin polymer particles in the hemostatic material of Abe et al. having an average primary particle diameter of 200 µm to 700 µm as Gulle et al. teaches of analogous hemostatic compositions having crosslinked gelatin particles having a size of 10 to 1,000 µm, especially 50 to 700 µm and Willard et al. teaches that microparticles contained in a hemostatic material having a size between 1 micrometer and 1,000 micrometers, such as about 500 µm predictably provide for accelerating the clotting of blood at a wound site.
Abe et al. does explicitly disclose that the plasticizer and/or paraffin are hydrophobic non-volatile solvents or that the first polysaccharide is dispersed in a hydrophobic solvent.
Abe et al. further discloses that the crosslinked polysaccharide composition may incorporate additives, such as plasticizers, solvent, petrolatum, paraffin, etc. as stated above.
Willard et al. further discloses that the crosslinked polysaccharides hemostatic composition includes other additives including plasticizers, such as oil of vegetable origin (such as castor oil), pine oil, etc. in an amount of 1-70 wt.% to impart flexibility to the film (p4, [0041],[0043]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a vegetable oil and/or substitute a vegetable oil, such as castor oil, for paraffin within the hemostatic composition of Abe et al., as Abe et al. teaches that plasticizers are appropriate additives for hemostatic materials and Willard et al. teach that the castor oil plasticizer imparts flexibility to hemostatic materials.
Therefore, one of ordinary skill in the art would be motivated to use castor oil, as taught by Willard et al. for the hemostatic composition of Abe et al. to predictably impart flexibility to the resulting hemostatic composition film or sheet.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the hemostatic composition of Abe et al. and the hemostatic composition of the instant claims comprise an analogous one pot mixture of a.) a crosslinkable polysaccharide derivative comprising at least one active ester group, b.) a polypeptide or polysaccharide polymer, and c.) paraffin and/or plasticizers wherein the paraffin and/or plasticizers have the same properties and are capable of the same functions, such as dispersing a first polysaccharide.
The amount of hydrophobic solvent of the instant claims 1,2,6,9-11 and 13 is not identified and can be included any amount, such as in less than 1% and therefore, the amount of first polysaccharide dispersed in the plasticizers (vegetable oil), paraffin, petrolatum, etc. can be minimal in the hemostatic material of the instant claims.
Abe et al. does not disclose a kinematic viscosity of the hydrophobic solvent is that of the instant
claim 11 or that the hydrophobic solvent is 30% by mass to 80% by mass with respects to a total mass of
the hemostatic material composition.
Willard et al. discloses that the hemostatic composition includes plasticizer, oil of vegetable origin (such as castor oil) in an amount of 1-70 wt.% to impart flexibility to the film or sheet (p4, [0041]).
The castor oil has a kinematic viscosity at 25°C of 600-800 mm2/sec, as evidenced by Castor Oils safety data sheet 2023 (p2, Other data).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the castor oil is a hydrophobic non-volatile solvent capable of a kinematic viscosity at 25°C is 1 mm2/sec to 1,000 mm2/sec as Univar Solutions2023 discloses that castor oil has a kinematic viscosity at 25°C of 600-800 mm2/sec.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a vegetable oil and/or substitute a vegetable oil, such as castor oil, for paraffin within the hemostatic composition of Abe et al., as Abe et al. teaches that plasticizers are appropriate additives for hemostatic materials and Willard et al. teach that the castor oil plasticizer imparts flexibility to hemostatic materials and therefore, it would have been predictable to include the hydrophobic solvent/plasticizer, such as castor oil is 30% by mass to 80% by mass with respects to a total mass of the crosslinked polysaccharide composition of Abe et al. as castor oil in an amount of 1-70 wt.% advantageously imparts flexibility to a crosslinked polysaccharide hemostatic composition film or sheet.
Products of identical chemical composition can not have mutually exclusive properties. A chemical composition and its properties are inseparable. Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim
patentable and does not render the old composition patentably new to the discoverer. In re Best, 562
F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977)
Response to Arguments
Applicant's arguments filed 2/11/26 have been fully considered but they are not persuasive.
Applicant asserts that the hemostatic material composition of the instant claims contains a hydrophobic solvent, and the polysaccharide (a first polysaccharide) is present in a dispersed state in the hydrophobic solvent. Since the reactive groups possessed by the first polysaccharide are less likely to be decomposed in the hydrophobic solvent, excellent storage stability of the hemostatic material can be exhibited.
The Examiner asserts that the references of Abe and Willard teach that stated above
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a vegetable oil and/or substitute a vegetable oil, such as castor oil, for paraffin within the hemostatic composition of Abe et al., as Abe et al. teaches that plasticizers are appropriate additives for hemostatic materials and Willard et al. teach that the castor oil plasticizer imparts flexibility to hemostatic materials and therefore, it would have been predictable to include the hydrophobic solvent/plasticizer, such as castor oil is 30% by mass to 80% by mass with respects to a total mass of the crosslinked polysaccharide composition of Abe et al. as castor oil in an amount of 1-70 wt.% advantageously imparts flexibility to a crosslinked polysaccharide hemostatic composition film or sheet.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that the hemostatic composition of Abe et al. and the hemostatic composition of the instant claims comprise an analogous one pot mixture of a.) a crosslinkable polysaccharide derivative comprising at least one active ester group, b.) a polypeptide or polysaccharide polymer, and c.) paraffin and/or plasticizers and the paraffin and/or plasticizers have the same properties and are capable of the same functions, such as dispersing a first polysaccharide.
Therefore, one of ordinary skill in the art would be motivated to use castor oil, as taught by
Willard et al. for the hemostatic composition of Abe et al. to predictably impart flexibility to the resulting hemostatic composition film or sheet.
The amount of hydrophobic solvent of the instant claims 1,2,6,9-11 and 13 is not identified and
can be included in less than 1% and therefore, the amount of first polysaccharide dispersed in the
plasticizers (vegetable oil), paraffin, petrolatum, etc. can be minimal in the hemostatic material of the instant claims.
The statement of “reactive groups possessed by the first polysaccharide are less likely to be decomposed in the hydrophobic solvent, excellent storage stability of the hemostatic material can be exhibited” is a subjective statement and does not provide any quantitative data.
The arguments of counsel cannot take the place of evidence in the record. Examples of attorney statements are not evidence and must be supported by an appropriate affidavit or declaration include statements regarding unexpected results. MPEP § 716.01 (c).
Applicant asserts that the hemostatic composition of the instant claims includes crosslinked particles, and the crosslinked particles absorb a trace amount of water in the composition or the like, the decomposition of the specific polysaccharide is suppressed and excellent storage can be exhibited.
The references of Abe, Gulle and Willard are stated above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include crosslinked gelatin polymer particles in the hemostatic material of Abe et al. having an average primary particle diameter of 200 µm to 700 µm as Gulle et al. teaches of analogous hemostatic compositions having crosslinked gelatin particles having a size of 10 to 1,000 µm, especially 50 to 700 µm and Willard et al. teaches that microparticles contained in a hemostatic material having a size between 1 micrometer and 1,000 micrometers, such as about 500 µm predictably provide for accelerating the clotting of blood at a wound site.
The crosslinked particles comprise crosslinked polypeptide (gelatin) having a size of 10 to 1,000
µm, especially 50 to 700 µm and encompass the crosslinked particles of the instant claims and therefore, have the same properties and are capable of the same functions, such as absorbing a trace amount of water, suppressing decomposition of the specific polysaccharide and exhibiting excellent storage stability.
Applicant asserts that even if a plasticizer such as vegetable oil disclosed in Willard is added to the medical treatment material of Abe, the crosslinkable polysaccharide derivative of Abe will not spontaneously be dispersed in the plasticizer (vegetable oil). Generally, in order to disperse a polysaccharide in a hydrophobic solvent, it is necessary to add an emulsifier or a surfactant, or to perform a special dispersion operation.
The Examiner asserts that the hemostatic composition of Abe et al. and the hemostatic composition of the instant claims comprise an analogous one pot mixture of a.) a crosslinkable polysaccharide derivative comprising at least one active ester group, b.) a polypeptide or polysaccharide polymer, and c.) paraffin and/or plasticizers wherein the paraffin and/or plasticizers have the same properties and are capable of the same functions, such as dispersing a first polysaccharide as well as that stated above.
The reference of Abe teaches that additives, such as surfactants are added to the hemostatic composition.
Applicant asserts that the medical treatment of Abe is premised on its function that the crosslinkable polysaccharide derivative reacts under an aqueous environment to form a crosslinked product. Therefore, if the crosslinkable polysaccharide derivative contained in the medical treatment material of Abe is dispersed in a hydrophobic solvent, its function will be impaired.
The instant claims are drawn to a composition comprising individual components a.) a first polysaccharide having a reactive group, b.) a crosslinked protein or a crosslinked polysaccharide, and c.) a hydrophobic solvent (paraffin) mixed in one pot and is not drawn to the method of preparing a
hemostatic material.
The instant claims do not exclude crosslinking of the first polysaccharide with the crosslinked protein or crosslinked (second) polysaccharide in an aqueous environment to prepare a hemostatic material composition.
The reference of Abe teaches of a composition comprising individual components a.) a first polysaccharide having a reactive group, b.) a crosslinked protein or a crosslinked polysaccharide, and c.) paraffin mixed in one pot and was not used to teach of mixing the individual components in an aqueous solution as well as that stated above.
The reference of Willard is stated above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a vegetable oil and/or substitute a vegetable oil, such as castor oil, for paraffin within the hemostatic composition of Abe et al., as Abe et al. teaches that plasticizers are appropriate additives for hemostatic materials and Willard et al. teach that the castor oil plasticizer imparts flexibility to hemostatic materials and therefore, it would have been predictable to include the hydrophobic solvent/plasticizer, such as castor oil is 30% by mass to 80% by mass with respects to a total mass of the crosslinked polysaccharide composition of Abe et al. as castor oil in an amount of 1-70 wt.% advantageously imparts flexibility to a crosslinked polysaccharide hemostatic composition film or sheet.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double
patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1,2,6 and 9-13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 and 16 of copending Application No. 18/062,575 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the hemostatic material composition of the instant claims comprises a polysaccharide having a reactive group, hydrophobic solvent and a crosslinked particle that encompasses the hemostatic material composition comprising a polysaccharide having a reactive group, hydrophobic solvent and a crosslinked particle of copending Application No. 18/062,575.
The polysaccharide of the instant claims and of copending Application No. 18/062,575 may both comprise cellulose, dextran, dextrin, pullulan, etc.
The polysaccharide reactive group of the instant claims and of copending Application No. 18/062,575 may both comprise an N-hydroxysuccinimide ester group and is represented by General
Formula (1).
The content of the constitutional unit derived from the monosaccharide having the reactive group is 1% by mole to 40% by mole with respect to 100% by mole of the polysaccharide the instant claims is analogous to that of copending Application No. 18/062,575.
The weight average molecular weight of the polysaccharide is 2,000 to 2,500,000 of the instant claims is analogous to that of copending Application No. 18/062,575.
The hydrophobic solvent of the instant claims and of copending Application No. 18/062,575 may both comprise vegetable oil, paraffin-based solvent, an olefin-based solvent, a silicone-based solvent, etc. with a kinematic viscosity at 25[Symbol font/0xB0]C is 1 mm2/sec to 1,000 mm2/sec.
The content of the hydrophobic solvent is 30% by mass to 70% by mass with respect to a total
mass of the hemostatic material composition of the instant claims is analogous to that of copending Application No. 18/062,575.
The crosslinked particle of the instant claims and of copending Application No. 18/062,575 may both comprise a crosslinked protein or a crosslinked polysaccharide.
The average particle diameter of 200 µm to 700 µm of the instant claims encompasses the 20 µm to 500 µm of copending Application No. 18/062,575.
The hemostatic material of the instant claims does not contain water and the hemostatic material of copending Application No. 18/062,575 does not necessarily comprise water as the constituents of the composition comprise polysaccharide having a reactive group, hydrophobic solvent and a crosslinked particle.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed 2/11/26 have been fully considered but they are not persuasive.
Applicant requests that the double patenting rejection be held in abeyance.
The rejection is not held in abeyance and is maintained.
Conclusion
No claims are allowed at this time.
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/MELISSA J PERREIRA/ Examiner, Art Unit 1618